New York, NY (Press Release) – SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS” or the “Company”), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the devel­op­ment of novel cancer immuno­therapies for a broad range of cancer indi­ca­tions, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track desig­na­tion to the Company’s lead asset, galin­pepimut-S (GPS), for the treat­ment of multiple myeloma (MM). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types.

The Company reported final clin­i­cal and immunological data from a Phase 2 clin­i­cal trial for GPS in the treat­ment of high-risk multiple myeloma at the 44th Annual European Society for Blood and Marrow Transplantation (EBMT) Meeting on March 19, 2018.

The FDA's Fast Track pro­gram facilitates the devel­op­ment of drugs intended to treat serious con­di­tions that have the poten­tial to address unmet medical needs. A prod­uct can­di­date with Fast Track status is afforded greater access to the FDA for the pur­pose of expediting the prod­uct can­di­date’s devel­op­ment, review and poten­tial approval. For a prod­uct can­di­date with Fast Track desig­na­tion, the FDA may con­sider sections of its Biologics License Application (BLA) for review on a rolling basis before the com­plete appli­ca­tion is submitted if relevant criteria are met.

“The desig­na­tion of Fast Track for GPS rep­re­sents important recognition by the FDA of the poten­tial of this novel immuno­therapeutic to address the sig­nif­i­cant unmet need in the treat­ment of patients with high-risk multiple myeloma in patients with poor-risk cytogenetics at diag­nosis who still harbor minimal residual disease (MRD) after au­tol­o­gous stem cell trans­plant,” said Angelos Stergiou, M.D., Sc.D. h.c., Pres­i­dent and Chief Executive Officer of SELLAS. “We are fully committed to work­ing closely with the FDA as we con­tinue devel­op­ment of our poten­tial first-in-class novel WT1-targeting cancer vac­cine for select high-risk MM patients in the post-autotransplant main­te­nance setting after standard first-line treat­ment.”

About the Phase 2 GPS multiple myeloma study

The open-label Phase 2 study consisted of 19 patients with multiple myeloma who had high-risk cytogenetics at initial diag­nosis and remained at least minimal residual disease (MRD)-positive after a successful au­tol­o­gous stem cell trans­plant (“ASCT”). GPS was admin­istered to patients in the study who achieved a stable disease or better status (per Inter­na­tional Myeloma Work­ing Group criteria) fol­low­ing ASCT. GPS was eval­u­ated as consolidation ther­apy to poten­tially stimulate a highly-specific immune response against WT1 in order to prevent or delay myeloma pro­gres­sion. Median pro­gres­sion-free survival (PFS) of 23.6 months was reported in the high-risk disease setting, compared to historically inferior out­comes while on an immuno­modu­la­tory drug (IMID) or pro­te­a­some inhibitor post-ASCT main­te­nance. Median over­all survival has not been reached to date. GPS stimulated time-dependent and robust CD4+ T cell or CD8+ T cell immune responses (IRs) specific for all four WT1 peptides within GPS, two of which are heteroclitic (mutated, by design). In addi­tion, GPS stimulated similar IRs against the two counterpart native peptides. The IRs were con­firmed in up to 91% of patients across HLA allele types, with multivalent IRs emerging in up to 64% of patients. Multi­functional cross-epitope T cell reactivity was observed in 75% of patients to an­ti­genic epitopes against which hosts were not specifically immunized, in a pattern akin to epitope spreading. A link of clin­i­cal activity to an­ti­gen-specific immune responses was suggested.

About Galin­pepimut-S (GPS)

GPS is a heteroclitic multivalent, multi-peptide cancer immuno­therapeutic agent composed of four peptides, addressing over 20 epitopes, and derived from the WT1 protein, which has been ranked by the National Cancer Institute as a top priority among cancer an­ti­gens for immuno­therapy. Importantly, because the WT1 an­ti­gen is overexpressed in many malig­nan­cies, and is not found in most normal tissues, GPS has the poten­tial to be a broad immuno­therapy, effective across a multitude of diverse cancer types and patient pop­u­la­tions.

About SELLAS

SELLAS is a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on novel cancer immuno­therapeutics for a broad range of cancer indi­ca­tions. SELLAS’ lead prod­uct can­di­date, galin­pepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has poten­tial as a mono­therapy or in com­bi­na­tion to address a broad spectrum of hema­to­logic malig­nan­cies and solid tumor indi­ca­tions. SELLAS has Phase 3 clin­i­cal trials planned (pending funding avail­a­bil­ity) for GPS in two indi­ca­tions, acute myeloid leukemia (AML) and malignant pleural mesothelioma (MPM) and is also devel­op­ing GPS as a poten­tial treat­ment for multiple myeloma (MM) and ovarian cancer. SELLAS plans to study GPS in up to four addi­tional indi­ca­tions. SELLAS has received Orphan Drug desig­na­tions for GPS from the U.S. Food & Drug Admin­istra­tion (FDA) for AML, MPM, and MM, as well as from the European Medicines Agency, for AML and MPM; GPS also received Fast Track desig­na­tion for AML and MPM from the FDA. SELLAS’ second prod­uct can­di­date, NeuVax™ (nelipepimut-S), is a HER2-directed cancer immuno­therapy being in­ves­ti­gated for the prevention of the recurrence of breast cancer after standard of care treat­ment in the adjuvant setting. NeuVax™ has received Fast Track status desig­na­tion by FDA for the treat­ment of patients with early stage breast cancer with low to intermediate HER2 ex­pres­sion, other­wise known as HER2 1+ or 2+, fol­low­ing standard of care.

For more in­­for­ma­tion on SELLAS, please visit www.sellaslifesciences.com

Forward-Looking Statements

This press release con­tains forward-looking state­ments, in­­clud­ing, but not limited to, state­ments related to the results of clin­i­cal studies and as to further devel­op­ment of GPS for ovarian cancer as well as for a broad range of cancer indi­ca­tions, in­­clud­ing the timing of clin­i­cal trials. These forward-looking state­ments are based on current plans, objectives, esti­mates, ex­pec­ta­tions and intentions, and in­her­ently involve sig­nif­i­cant risks and un­cer­tain­ties. Actual results and the timing of events could differ materially from those antic­i­pated in such forward-looking state­ments as a result of these risks and un­cer­tain­ties, which in­clude, without limitation, risks and un­cer­tain­ties asso­ci­ated with immune-oncology prod­uct devel­op­ment and clin­i­cal success thereof, the uncertainty of regu­la­tory approval, and other risks and un­cer­tain­ties affecting SELLAS and its devel­op­ment pro­grams. These risks and un­cer­tain­ties are described more fully in SELLAS’ Annual Report on Form 10-K and other filings with the Securities and Exchange Com­mis­sion. Other risks and un­cer­tain­ties of which SELLAS is not cur­rently aware may also affect SELLAS’ forward-looking state­ments. The forward-looking state­ments herein are made only as of the date hereof. SELLAS under­takes no obli­ga­tion to update or supple­ment any forward-looking state­ments to reflect actual results, new in­­for­ma­tion, future events, changes in its ex­pec­ta­tions or other cir­cum­stances that exist after the date as of which the forward-looking state­ments were made.

Source: SELLAS.